A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults
NCT ID: NCT02915809
Last Updated: 2016-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
414 participants
INTERVENTIONAL
2016-10-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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GC3110B Vaccine Group
Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).
GC3110B vaccine
0.5mL, Intramuscular
GCFLU Quadrivalent Inj.
Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).
GCFLU Quadrivalent Inj. vaccine
0.5mL, Intramuscular
Interventions
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GC3110B vaccine
0.5mL, Intramuscular
GCFLU Quadrivalent Inj. vaccine
0.5mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study
Exclusion Criteria
* Personal history of Guillain-Barré syndrome
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
18 Years
60 Years
ALL
Yes
Sponsors
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Green Cross Corporation
INDUSTRY
Responsible Party
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Other Identifiers
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GC3110B_P3
Identifier Type: -
Identifier Source: org_study_id
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